The gender question

For years, doctors treated women the same as men, but research may change that

February 18, 2010|By Laura Vozzella | laura.vozzella@baltsun.com

Amid the shortage of swine flu vaccine last fall, a Johns Hopkins immunology expert proposed a surprisingly simple-sounding fix: Give women a smaller dose than men so there would be more to go around.

Because women's bodies have been shown to generate a stronger antibody response than men's, the argument went, a smaller dose would be enough.

The proposal - made in a New York Times opinion article - was so well-received that the World Health Organization asked Sabra Klein of Hopkins' Bloomberg School of Public Health to draft a paper on it. But so far as Klein knows, no one has put the proposal into widespread clinical practice.

"One physician wrote me to say he felt comfortable giving his wife half a dose," said Klein, an assistant professor in molecular microbiology and immunology.

A rapidly growing body of research shows men and women are biologically different in ways that have nothing to do with the obvious physical features and lots to do with which diseases strike and how successfully or not the body fights them off. Differences in metabolism, brain structure and chemistry, lung development, hormones and chromosomes might affect such things as how well medicines work, whether patients recover language after a stroke and, possibly, how many cigarettes it takes to kill them.

But for the most part, the idea that males and females are very different patients hasn't made its way into the doctor's office.

"We really do often strive for this one-size-fits-all in medicine," said Klein. "Our biology is different. Whether you're talking about responses to pain or chemotherapy, it can result in differences in how we respond to treatment. ... There needs to be a better appreciation of these differences."

Only in recent decades have researchers come to suspect that basic biological differences might account for such things as why autism is four times more common in males or why lupus and irritable bowel syndrome predominantly afflict females.

"Until recently, women were often excluded from pharmaceutical studies," said John Vandenbergh, a retired North Carolina State University biology professor who participated in a landmark study of sex differences. "That was done on purpose ... and [the] reason was, it may affect fetal development. 'Why don't we do just males?' That all made sense until we realized males and females are truly different."

Since 1993, federally funded research and drug trials have been required by law to include women. But even today, researchers and drug and medical-device companies do not always break out the results of their studies by sex. That can mean missing red flags before a drug or device goes on the market, said Florence Haseltine, a reproductive endocrinologist who in 1990 formed the Society for Women's Health Research.

"When you give medications, often one sex - if it's going to have bad side effects - is the canary in the coal mine," Haseltine said. She noted the antihistamine Seldane was pulled off the market in 1998 after women taking it experienced cardiac arrhythmia.

Sex-based information is also lacking when it comes to public health data. Klein, the Hopkins researcher, has been frustrated that swine flu data is not consistently broken down by patients' sex. What sex-based information is out there - Canada and the state of California made note of it - indicates that the H1N1 virus strikes women particularly hard; about 70 percent of flu patients requiring hospitalization last year were women, data from Canada and California show.Statistically, Klein said, there does seem to be something about swine flu vulnerability and being female. But it's difficult to study that, she said, when most states do not report swine flu cases by sex. Despite those lapses, more attention has been paid to sex differences in the past decade, in large part because of a book-length 2001 report by the Institute of Medicine, "Exploring the Biological Contributions to Human Health: Does Sex Matter?"

"Up until the point of the IOM report, people always thought that women and men were basically the same, except for the hormones," said Dr. Michael Lockshin, a rheumatologist and Cornell Medical College professor who participated in the report. "In fact, there's pretty profound differences in biology between the sexes, and that biology may have relevance to most of what we talk about in human disease."

The report's findings have been slow to trickle into medical research, he said.

"At the time the IOM book was done, I used to raise my hand - in New York, we interrupt speakers at forums - and the speaker would say, 'Uh-oh, you're going to ask me that sex question again.' I got to be known as a gadfly on that. But what's happening now, I don't have to ask the question. The speaker is getting to it on his own."

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